Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-30 @ 1:50 PM
Study NCT ID:
NCT06821906
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiosurgery in the Treatment of Essential Tremor
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Study Overview
Official Title:
Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASIER
Brief Summary:
The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients
Detailed Description:
The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years.
After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:
1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy
2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy
The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.
After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:
1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy
2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy
The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: